Scandinavian Urethroplasty Study. A Multicentre, Prospective, Randomized Study Comparing Bulbar Urethroplasty With Excision and Primary Anastomosis or With an Onlay Grafting Procedure Using Buccal Mucosa.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 8
- 主要终点
- Penile complications
研究概览
简要总结
A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.
详细描述
The study is a prospective, randomized study to compare two common techniques of urethroplasty used to treat bulbar urethral strictures. One technique is excision of the stricture and end-to-end anastomosis of the urethra. The other technique is an onlay grafting procedure with buccal mucosa where the corpus spongiosum is not divided. The study is designed to compare complications of sexual and penile function, and is not powered to compare the success rates of the two techniques. The primary endpoint will be degree of erectile dysfunction and penile complications. The secondary endpoint will be restricturing leading to reoperation, and other complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm
- •Patient is able and willing to sign informed consent
- •Patient is able and willing to complete all study requirements
排除标准
- •Previous open urethroplasty
- •Previous hypospadia surgery
- •Previous surgery for congenital curvature or Mb Peyronie
- •Previous pelvic irradiation therapy
- •Known grave psychiatric disorder
- •Haemophilia or other clotting disorders that cause bleeding diathesis
- •Use of medication to increase erectile function, such as PDE5-inhibitors and intracavernous injections, during the study
- •Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
结局指标
主要结局
Penile complications
时间窗: up to one year
Measured by questionnaire made for this study
Degree of erectile dysfunction after surgery
时间窗: up to one year
Measured by changes in IIEF-5
次要结局
- Occurrence of complications(From operation to one year)
- Occurrence of failure within the follow up period(One year)
研究者
Ole Jacob Nilsen
Consultant, Head of section
Oslo University Hospital